How Should Drug and Natural Health Product Companies Report Safety Information?

Official title: Consultation: Draft guidance on preparing and submitting summary reports for marketed drugs and natural health products

Closed Regulations & Permits Health & Safety
Health Canada wants to update the rules for how drug and natural health product companies report safety information. Right now, companies must submit regular reports on the risks and benefits of their products. The new guidance aims to make these requirements clearer and easier to follow.

Why This Matters

This is mainly for pharmaceutical and natural health product companies, not everyday Canadians. But these reporting rules help Health Canada catch safety problems with medications and supplements you might use. Better reporting means faster action when a product turns out to be risky.

What Could Change

Companies selling drugs and natural health products in Canada would follow updated reporting requirements. The guidance consolidates existing rules into plain language. A new notification form would standardize how companies report significant changes in product risks or benefits.

Key Issues

  • Are the updated guidance documents clear and easy to follow?
  • Does the new notification form capture the right information about product risk changes?
  • How do these requirements relate to other pharmacovigilance guidance being developed?

How to Participate

  1. Review the draft guidance on preparing and submitting summary reports and the draft notification form.
  2. Send your comments by email to mhpdpolicy-politiquesdpsc@hc-sc.gc.ca with the subject line "Summary Reporting Guidance – Consultation Comments" by December 23, 2025.

Key Documents